Page 1/8

Safety Data Sheet

acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

* 1 Identification
· Product identifier
· Trade name: Variolink Esthetic DC (Base)
· Relevant identified uses of the substance or mixture and uses advised against
No further relevant information available.
· Application of the substance / the mixture Dual-curing resin-based dental luting material
· Details of the supplier of the safety data sheet
· Manufacturer/Supplier:
Ivoclar Vivadent Inc.
175 Pineview Drive, Amherst, N.Y. 14228
USA
Tel. +1 800 533 6825
Fax +1 716 691 2285

Ivoclar Vivadent Inc.

1-6600 Dixie Road
Mississauga, Ontario
L5T 2Y2
Canada
Phone: +1 905 670 8499
Fax: +1 905 670 3102
· Information department: Quality Assurance / Regulatory Affairs
· Emergency telephone number:
24 Hour Emergency Assistance:
Emergency-Call USA - Infotrac: 1-800-535-5053
Emergency-Call Canada - Canutec: 1-613-996-6666

General SDS Assistance:

US: 1-800-533-6825
Canada: 1-800-263-8182

* 2 Hazard(s) identification
· Classification of the substance or mixture
Skin Irrit. 2 H315 Causes skin irritation.
Eye Irrit. 2A H319 Causes serious eye irritation.
Skin Sens. 1 H317 May cause an allergic skin reaction.
STOT SE 3 H335 May cause respiratory irritation.
· Label elements
· GHS label elements
The product is classified and labeled according to the Globally Harmonized System (GHS).
· Hazard pictograms

GHS07

· Signal word Warning

· Hazard-determining components of labeling:
urethane dimethacrylate
ytterbium trifluoride
(Contd. on page 2)
US

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 Page 2/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 1)
1,10-decandiol dimethacrylate
· Hazard statements
Causes skin irritation.
Causes serious eye irritation.
May cause an allergic skin reaction.
May cause respiratory irritation.
· Precautionary statements
Wear protective gloves/protective clothing/eye protection/face protection.
Wash contaminated clothing before reuse.
If skin irritation or rash occurs: Get medical advice/attention.
If eye irritation persists: Get medical advice/attention.
Dispose of contents/container in accordance with local/regional/national/international regulations.
· Additional information:
Medical devices are exempt from the labeling provisions of GHS according to the Hazard Communication
Standard (HCS).
· Classification system:
· NFPA ratings (scale 0 - 4)
Health = 1
0 Fire = 0
1 0 Reactivity = 0
· HMIS-ratings (scale 0 - 4)
HEALTH 1 Health = 1
FIRE 0 Fire = 0
REACTIVITY 0 Reactivity = 0
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Description: Mixture of the substances listed below with nonhazardous additions.
· Dangerous components:
13760-80-0 ytterbium trifluoride 20-<25%
72869-86-4 urethane dimethacrylate 2.5-<10%
1830-78-0 glycerin-1.3-dimethacrylate 2.5-<10%
6701-13-9 1,10-decandiol dimethacrylate 2.5-<10%
591-08-2 acetyl-2-thiourea 0.1-<1%

4 First-aid measures
· Description of first aid measures
· After inhalation:
Supply fresh air and to be sure call for a doctor.
In case of unconsciousness place patient stably in side position for transportation.
· After skin contact:
Rinse with water.
If skin irritation continues, consult a doctor.
(Contd. on page 3)
US

40.1.5
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 2)
· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.
· After swallowing:
Rinse out mouth and then drink plenty of water.
If symptoms persist consult doctor.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed No further relevant information available.
· Indication of any immediate medical attention and special treatment needed
No further relevant information available.

5 Fire-fighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
· Special hazards arising from the substance or mixture No further relevant information available.
· Advice for firefighters
· Protective equipment: No special measures required.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.
· Environmental precautions: Do not allow to enter sewers/ surface or ground water.
· Methods and material for containment and cleaning up: Pick up mechanically.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for disposal information.

7 Handling and storage

· Handling:
· Precautions for safe handling
Only adequately trained personnel should handle this product.
For use in dentistry only.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and receptacles: Store only in the original receptacle.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions:
Protect from exposure to the light.
Protect from heat and direct sunlight.
Keep receptacle tightly sealed.
· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical systems: No further data; see item 7.
(Contd. on page 4)
US

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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 3)

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the creation were used as basis.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Usual hygienic measures for dental practice.
Keep away from foodstuffs, beverages and feed.
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
· Breathing equipment: Not required.
· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
After use of gloves apply skin-cleaning agents and skin cosmetics.
· Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the
resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the
application.
· Penetration time of glove material
The exact break through time has to be found out by the manufacturer of the protective gloves and has to be
observed.
· Not suitable are gloves made of the following materials:
Commercial medical gloves do not provide protection against the sensitizing effect of methacrylates.
· Eye protection: Safety glasses

9 Physical and chemical properties

· Information on basic physical and chemical properties
· General Information
· Appearance:
Form: Pasty
Color: According to product specification
· Odor: Characteristic
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
· Flash point: Not applicable.
· Flammability (solid, gaseous): Not determined.
· Auto igniting: Product is not selfigniting.
· Danger of explosion: Product does not present an explosion hazard.
(Contd. on page 5)
US

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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 4)

· Explosion limits:
Lower: Not determined.
Upper: Not determined.
· Vapor pressure: Not applicable.
· Density at 20 °C (68 °F): 1.8567 g/cm³ (15.494 lbs/gal)
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Nearly insoluble.
· Partition coefficient (n-octanol/water): Not determined.
· Viscosity:
Dynamic: Not applicable.
Kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.
· Chemical stability
Stable under normal handling and storage conditions.
Photoreactive (Danger of polymerization).
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid
Protect from exposure to the light.
Keep away from heat and direct sunlight.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: None under normal conditions of storage and use.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: Irritant to skin and mucous membranes.
· on the eye: Irritating effect.
· Sensitization: Sensitization possible through skin contact.
· Additional toxicological information: No further relevant information available.
· Carcinogenic categories
· IARC (International Agency for Research on Cancer)
13760-80-0 ytterbium trifluoride 3
128-37-0 2,6-di-tert-butyl-p-cresol 3
· NTP (National Toxicology Program)
None of the ingredients is listed.
(Contd. on page 6)
US

40.1.5
 Page 6/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 5)
· OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Behavior in environmental systems:
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes:
Water hazard class 1 (Self-assessment): slightly hazardous for water
Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage
system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

13 Disposal considerations
· Waste treatment methods
· Recommendation:
Take to an approved landfill or a waste incineration plant, under conditions approved by the local authority.
· Uncleaned packagings:
· Recommendation: Disposal must be made according to official regulations.

14 Transport information
· UN-Number
· DOT, ADR, ADN, IMDG, IATA Void
· UN proper shipping name
· DOT, ADR, ADN, IMDG, IATA Void
· Transport hazard class(es)
· DOT, ADR, ADN, IMDG, IATA
· Class Void
· Packing group
· DOT, ADR, IMDG, IATA Void
· Environmental hazards:
· Marine pollutant: No
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of
MARPOL73/78 and the IBC Code Not applicable.
(Contd. on page 7)
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 6)

· Transport/Additional information: Product is not classified as a dangerous good for transport

(ADR, IMDG, IATA).
· UN "Model Regulation": -

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Sara
· Section 355 (extremely hazardous substances):
None of the ingredients is listed.
· Section 313 (Specific toxic chemical listings):
13395-16-9 copper(II) 4-oxopent-2-en-2-olate
· TSCA (Toxic Substances Control Act):
All ingredients are listed.
· Proposition 65
· Chemicals known to cause cancer:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for females:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for males:
None of the ingredients is listed.
· Chemicals known to cause developmental toxicity:
None of the ingredients is listed.
· Carcinogenic categories
· EPA (Environmental Protection Agency)
None of the ingredients is listed.
· TLV (Threshold Limit Value established by ACGIH)
13760-80-0 ytterbium trifluoride A4
128-37-0 2,6-di-tert-butyl-p-cresol A4
· NIOSH-Ca (National Institute for Occupational Safety and Health)
None of the ingredients is listed.
· GHS label elements
The product is classified and labeled according to the Globally Harmonized System (GHS).
· Hazard pictograms

GHS07

· Signal word Warning

· Hazard-determining components of labeling:
urethane dimethacrylate
ytterbium trifluoride
1,10-decandiol dimethacrylate
(Contd. on page 8)
US

40.1.5
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic DC (Base)

(Contd. of page 7)
· Hazard statements
Causes skin irritation.
Causes serious eye irritation.
May cause an allergic skin reaction.
May cause respiratory irritation.
· Precautionary statements
Wear protective gloves/protective clothing/eye protection/face protection.
Wash contaminated clothing before reuse.
If skin irritation or rash occurs: Get medical advice/attention.
If eye irritation persists: Get medical advice/attention.
Dispose of contents/container in accordance with local/regional/national/international regulations.
· National regulations:
· Other regulations, limitations and prohibitive regulations
The product is a medical device according to the Directive 93/42/EEC.
This product is classified as a medical device under US and Canadian regulations and has been reviewed by
the US Food and Drug Administration and Health Canada.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
This information is based on our present knowledge. However, this shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Date of preparation / last revision 05/07/2015 / 1
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International
Carriage of Dangerous Goods by Road)
IMDG: International Maritime Code for Dangerous Goods
DOT: US Department of Transportation
IATA: International Air Transport Association
ACGIH: American Conference of Governmental Industrial Hygienists
EINECS: European Inventory of Existing Commercial Chemical Substances
ELINCS: European List of Notified Chemical Substances
CAS: Chemical Abstracts Service (division of the American Chemical Society)
NFPA: National Fire Protection Association (USA)
HMIS: Hazardous Materials Identification System (USA)
Skin Irrit. 2: Skin corrosion/irritation, Hazard Category 2
Eye Irrit. 2A: Serious eye damage/eye irritation, Hazard Category 2A
Skin Sens. 1: Sensitisation - Skin, Hazard Category 1
STOT SE 3: Specific target organ toxicity - Single exposure, Hazard Category 3
· * Data compared to the previous version altered.
US

40.1.5
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

* 1 Identification
· Product identifier
· Trade name: Variolink Esthetic LC
· Relevant identified uses of the substance or mixture and uses advised against
No further relevant information available.
· Application of the substance / the mixture
Light-curing dental luting composite suitable for ceramic and composite restorations
· Details of the supplier of the safety data sheet
· Manufacturer/Supplier:
Ivoclar Vivadent Inc.
175 Pineview Drive, Amherst, N.Y. 14228
USA
Tel. +1 800 533 6825
Fax +1 716 691 2285

Ivoclar Vivadent Inc.

1-6600 Dixie Road
Mississauga, Ontario
L5T 2Y2
Canada
Phone: +1 905 670 8499
Fax: +1 905 670 3102
· Information department: Quality Assurance / Regulatory Affairs
· Emergency telephone number:
24 Hour Emergency Assistance:
Emergency-Call USA - Infotrac: 1-800-535-5053
Emergency-Call Canada - Canutec: 1-613-996-6666

General SDS Assistance:

US: 1-800-533-6825
Canada: 1-800-263-8182

* 2 Hazard(s) identification
· Classification of the substance or mixture
Skin Irrit. 2 H315 Causes skin irritation.
Eye Irrit. 2A H319 Causes serious eye irritation.
Skin Sens. 1 H317 May cause an allergic skin reaction.
STOT SE 3 H335 May cause respiratory irritation.
· Label elements
· GHS label elements
The product is classified and labeled according to the Globally Harmonized System (GHS).
· Hazard pictograms

GHS07

· Signal word Warning

· Hazard-determining components of labeling:
urethane dimethacrylate
(Contd. on page 2)
US

40.1.5
 Page 2/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 1)
ytterbium trifluoride
1,10-decandiol dimethacrylate
· Hazard statements
Causes skin irritation.
Causes serious eye irritation.
May cause an allergic skin reaction.
May cause respiratory irritation.
· Precautionary statements
Wear protective gloves/protective clothing/eye protection/face protection.
Wash contaminated clothing before reuse.
If skin irritation or rash occurs: Get medical advice/attention.
If eye irritation persists: Get medical advice/attention.
Dispose of contents/container in accordance with local/regional/national/international regulations.
· Additional information:
Medical devices are exempt from the labeling provisions of GHS according to the Hazard Communication
Standard (HCS).
· Classification system:
· NFPA ratings (scale 0 - 4)
Health = 1
0 Fire = 0
1 0 Reactivity = 0
· HMIS-ratings (scale 0 - 4)
HEALTH 1 Health = 1
FIRE 0 Fire = 0
REACTIVITY 0 Reactivity = 0
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Description: Mixture of the substances listed below with nonhazardous additions.
· Dangerous components:
13760-80-0 ytterbium trifluoride 20-<25%
72869-86-4 urethane dimethacrylate 2.5-<10%
1830-78-0 glycerin-1.3-dimethacrylate 2.5-<10%
6701-13-9 1,10-decandiol dimethacrylate 2.5-<10%

4 First-aid measures
· Description of first aid measures
· After inhalation:
Supply fresh air and to be sure call for a doctor.
In case of unconsciousness place patient stably in side position for transportation.
· After skin contact:
Rinse with water.
If skin irritation continues, consult a doctor.
(Contd. on page 3)
US

40.1.5
 Page 3/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 2)
· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.
· After swallowing:
Rinse out mouth and then drink plenty of water.
If symptoms persist consult doctor.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed No further relevant information available.
· Indication of any immediate medical attention and special treatment needed
No further relevant information available.

5 Fire-fighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
· Special hazards arising from the substance or mixture No further relevant information available.
· Advice for firefighters
· Protective equipment: No special measures required.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.
· Environmental precautions: Do not allow to enter sewers/ surface or ground water.
· Methods and material for containment and cleaning up: Pick up mechanically.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for disposal information.

7 Handling and storage

· Handling:
· Precautions for safe handling
Only adequately trained personnel should handle this product.
For use in dentistry only.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and receptacles: Store only in the original receptacle.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions:
Protect from exposure to the light.
Protect from heat and direct sunlight.
Keep receptacle tightly sealed.
· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical systems: No further data; see item 7.
(Contd. on page 4)
US

40.1.5
 Page 4/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 3)

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the creation were used as basis.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Usual hygienic measures for dental practice.
Keep away from foodstuffs, beverages and feed.
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
· Breathing equipment: Not required.
· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
After use of gloves apply skin-cleaning agents and skin cosmetics.
· Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the
resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the
application.
· Penetration time of glove material
The exact break through time has to be found out by the manufacturer of the protective gloves and has to be
observed.
· Not suitable are gloves made of the following materials:
Commercial medical gloves do not provide protection against the sensitizing effect of methacrylates.
· Eye protection: Safety glasses

9 Physical and chemical properties

· Information on basic physical and chemical properties
· General Information
· Appearance:
Form: Pasty
Color: According to product specification
· Odor: Characteristic
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
· Flash point: Not applicable.
· Flammability (solid, gaseous): Not determined.
· Auto igniting: Product is not selfigniting.
· Danger of explosion: Product does not present an explosion hazard.
(Contd. on page 5)
US

40.1.5
 Page 5/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 4)

· Explosion limits:
Lower: Not determined.
Upper: Not determined.
· Vapor pressure: Not applicable.
· Density at 20 °C (68 °F): 1.7924 g/cm³ (14.958 lbs/gal)
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Nearly insoluble.
· Partition coefficient (n-octanol/water): Not determined.
· Viscosity:
Dynamic: Not applicable.
Kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.
· Chemical stability
Stable under normal handling and storage conditions.
Photoreactive (Danger of polymerization).
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid
Protect from exposure to the light.
Keep away from heat and direct sunlight.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: None under normal conditions of storage and use.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: Irritant to skin and mucous membranes.
· on the eye: Irritating effect.
· Sensitization: Sensitization possible through skin contact.
· Additional toxicological information: No further relevant information available.
· Carcinogenic categories
· IARC (International Agency for Research on Cancer)
13760-80-0 ytterbium trifluoride 3
128-37-0 2,6-di-tert-butyl-p-cresol 3
· NTP (National Toxicology Program)
None of the ingredients is listed.
(Contd. on page 6)
US

40.1.5
 Page 6/8
Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 5)
· OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Behavior in environmental systems:
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes:
Water hazard class 1 (Self-assessment): slightly hazardous for water
Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage
system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

13 Disposal considerations
· Waste treatment methods
· Recommendation:
Take to an approved landfill or a waste incineration plant, under conditions approved by the local authority.
· Uncleaned packagings:
· Recommendation: Disposal must be made according to official regulations.

14 Transport information
· UN-Number
· DOT, ADR, ADN, IMDG, IATA Void
· UN proper shipping name
· DOT, ADR, ADN, IMDG, IATA Void
· Transport hazard class(es)
· DOT, ADR, ADN, IMDG, IATA
· Class Void
· Packing group
· DOT, ADR, IMDG, IATA Void
· Environmental hazards:
· Marine pollutant: No
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of
MARPOL73/78 and the IBC Code Not applicable.
(Contd. on page 7)
US

40.1.5
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 6)

· Transport/Additional information: Product is not classified as a dangerous good for transport

(ADR, IMDG, IATA).
· UN "Model Regulation": -

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Sara
· Section 355 (extremely hazardous substances):
None of the ingredients is listed.
· Section 313 (Specific toxic chemical listings):
None of the ingredients is listed.
· TSCA (Toxic Substances Control Act):
All ingredients are listed.
· Proposition 65
· Chemicals known to cause cancer:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for females:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for males:
None of the ingredients is listed.
· Chemicals known to cause developmental toxicity:
None of the ingredients is listed.
· Carcinogenic categories
· EPA (Environmental Protection Agency)
None of the ingredients is listed.
· TLV (Threshold Limit Value established by ACGIH)
13760-80-0 ytterbium trifluoride A4
128-37-0 2,6-di-tert-butyl-p-cresol A4
· NIOSH-Ca (National Institute for Occupational Safety and Health)
None of the ingredients is listed.
· GHS label elements
The product is classified and labeled according to the Globally Harmonized System (GHS).
· Hazard pictograms

GHS07

· Signal word Warning

· Hazard-determining components of labeling:
urethane dimethacrylate
ytterbium trifluoride
1,10-decandiol dimethacrylate
(Contd. on page 8)
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Safety Data Sheet
acc. to OSHA HCS
Printing date 05/07/2015 Version number 2 Reviewed on 03/12/2015

Trade name: Variolink Esthetic LC

(Contd. of page 7)
· Hazard statements
Causes skin irritation.
Causes serious eye irritation.
May cause an allergic skin reaction.
May cause respiratory irritation.
· Precautionary statements
Wear protective gloves/protective clothing/eye protection/face protection.
Wash contaminated clothing before reuse.
If skin irritation or rash occurs: Get medical advice/attention.
If eye irritation persists: Get medical advice/attention.
Dispose of contents/container in accordance with local/regional/national/international regulations.
· National regulations:
· Other regulations, limitations and prohibitive regulations
The product is a medical device according to the Directive 93/42/EEC.
This product is classified as a medical device under US and Canadian regulations and has been reviewed by
the US Food and Drug Administration and Health Canada.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
This information is based on our present knowledge. However, this shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Date of preparation / last revision 05/07/2015 / 1
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International
Carriage of Dangerous Goods by Road)
IMDG: International Maritime Code for Dangerous Goods
DOT: US Department of Transportation
IATA: International Air Transport Association
ACGIH: American Conference of Governmental Industrial Hygienists
EINECS: European Inventory of Existing Commercial Chemical Substances
ELINCS: European List of Notified Chemical Substances
CAS: Chemical Abstracts Service (division of the American Chemical Society)
NFPA: National Fire Protection Association (USA)
HMIS: Hazardous Materials Identification System (USA)
Skin Irrit. 2: Skin corrosion/irritation, Hazard Category 2
Eye Irrit. 2A: Serious eye damage/eye irritation, Hazard Category 2A
Skin Sens. 1: Sensitisation - Skin, Hazard Category 1
STOT SE 3: Specific target organ toxicity - Single exposure, Hazard Category 3
· * Data compared to the previous version altered.
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40.1.5